DiBenedetti D, Huang M-Y, Kosa K, Suthoff E, Bonthapally V, Lasser R, Pollack M, Doherty J, Mak C, Cutler AJ, Mattingly GW. Assessing individuals' experiences with zuranolone for major depressive disorder: qualitative interviews with participants from the open-label shoreline study. Poster presented at the 2023 ASCP Annual Meeting; May 31, 2023. Miami Beach, FL.


BACKGROUND: Pharmacological treatments for major depressive disorder (MDD) usually include daily use of antidepressant therapy (ADT) over extended periods of time.1 Zuranolone is an investigational drug being evaluated as a rapid-acting, once-daily, 14-day oral treatment in adults with MDD. We conducted qualitative interviews to further understand trial participants' experiences with and perceptions of this potential treatment for MDD.

METHODS: Two independent researchers conducted interviews using a convenience sample of participants with MDD who received zuranolone 50 mg once-daily for 14 days as part of the SHORELINE open-label study, responded to the initial treatment course, and remained in the study for ≥ 24 weeks.2 This qualitative study was run in parallel with but was not part of the SHORELINE study. Interview participants were asked about their experiences with MDD, their perceptions of zuranolone, and the meaningfulness and importance of treatment improvements. Interview data were analyzed using a thematic analysis approach. Denominators used for calculating percentages varied based on pretrial reporting of symptoms.

RESULTS: The mean age of the 32 interview participants was 40.6 years (range, 20-66 years) and 56.3% were male. Most participants (78.2%) had a prior history of MDD at enrollment in SHORELINE (mean, 12.6 years; range, 1-40 years); 81.3% had previously received an ADT. Before starting SHORELINE, participants generally reported low energy (96.9%), sleep problems (93.8%), feeling depressed/sad/hopeless (90.6%), fatigue/tiredness (84.4%), and that their MDD-related symptoms affected their work/school (87.5%), daily roles and responsibilities (84.4%), and social lives/activities/relationships (84.4%). All 32 participants reported an improvement in ≥ 1 MDD-related symptoms after receiving zuranolone, and most participants (87.5%) noticed improvements within the first week of treatment (range, 1 day-1 month). Participants noticed improvements in sleep (90.0%), feeling depressed/sad/hopeless (82.8%), anhedonia/apathy/lack of interest or desire (81.0%), and energy (80.6%). Many participants also noticed improvements in fatigue/tiredness (77.8%), self-worth/guilt/doubt (75.0%), short-term memory (75.0%), irritability (66.7%), motivation (61.5%), concentration/focus/attention (60.9%), appetite‌/eating habits (60.9%), and anxiety (59.1%). Furthermore, all participants who reported MDD-related impacts to their social lives, activities, or relationships before receiving zuranolone also reported improvements following treatment. Participants also reported improvements in their daily roles and responsibilities (92.6%) and work/school (82.1%) following zuranolone treatment. Of the 29 participants who described what they liked about zuranolone as a potential treatment for MDD, 75.9% liked that it helped manage their depression or another specific MDD-related symptom, 62.1% liked the 14-day treatment duration, 27.6% liked that they noticed improvements quickly, and 24.1% liked that they experienced little or no side effects. All participants reported being at least moderately satisfied with zuranolone, and 83.8% reported being “quite” or “very” satisfied.

CONCLUSION: Interviewed participants from SHORELINE observed rapid improvements in depressive symptoms, improvements in their daily lives and roles, and reported high satisfaction rates with zuranolone.

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